UnknownNot Applicable

Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

France10,000 participantsStarted 2021-03-25

Plain-language summary

To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance study, using two databases. First, disproportionality analysis in Vigibase®, the World Health Organization global database, will be perform between antidepressant drugs and neonatal hypotonia . Second, narratives from the French National Pharmacovigilance Database will be extracted.

Who can participate

Age range1 Day – 30 Days

SexALL

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Inclusion Criteria: * neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs Exclusion Criteria: * Reports with maternal suicide, congenital malformation and hypotonia occurring only during breastfeeding

What they're measuring

neonatal hypotonia

Timeframe: Case reported in the World Health Organization (WHO) pharmacovigilance database to April 1st 2021

Trial details

NCT IDNCT04830241

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-04-15

View on ClinicalTrials.gov More Neonatal Hypotonia trials